BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD WHITACRE SPINAL NEEDLE

    MDR report key: 958883 · Received December 4, 2007

    Report

    Report Number
    2618282-2007-00014
    Event Type
    Injury
    Date Received
    December 4, 2007
    Report Date
    October 29, 2007
    Manufacturer
    BECTON DICKINSON
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE BULK NON STERILE LOTS CONTAINED IN KIT PACKERS TRAY: LOT NUMBER 7100878, 2007; 7072259, 2007; 7058118, 2007; 7026402, 2007; 6248986, 2006; 6173782, 2006. EVALUATION SUMMARY: A SINGLE SPINAL NEEDLE WAS RETURNED FOR FAILURE ANALYSIS. MICROSCOPIC EXAMINATION OF RETURNED PIECES; THE HUB END PORTION AND THE CANNULA SECTION THAT FAILED AT EACH END EXHIBITED CHARACTERISTICS SUCH AS A STRONG RESIDUAL BEND AND TUBING OVALITY (A DEFORMATION FROM THE NORMAL CIRCULAR CROSS-SECTION) WHEN VIEWED TOGETHER IN CONTEXT, THESE ARE RELIABLE INDICATORS OF BENDING/RESTRAIGHTENING MODE OF FAILURE. FURTHER EVIDENCE OF TOOL MARKS, CRIMPING AND CRACKS OF THE FREE END MAY BE RESULTANT FROM SUBSEQUENT EFFORTS TO RETRIEVE THE FREE END. IN CONCLUSION ANALYSIS SUPPORT THE CONCLUSION THAT THE BREAKAGE REPORTED RESULTED FROM BENDING AND SUBSEQUENT RESTRAIGHTENING OF THE NEEDLE. NO EVIDENCE OF A MANUFACTURING RELATED FAILURE IS NOTED. THE FAILURE APPEARS TO BE DUE TO USER HANDLING AND THE INHERENT RISK OF THIS PROCEDURE. REPORTED INCIDENTS OF THIS NATURE ARE LESS THAN ONE IN TWO MILLION UNITS SOLD. THE VAST MAJORITY OF THESE INCIDENTS INVOLVE THE NEEDLE BEING BENT DURING THE PROCEDURE CAUSING THE NEEDLE TO BREAK WHEN RESTRAIGHTENED. OFTEN IF AN INTRODUCER IS USED AND IF THE BENT NEEDLE IS PULLED BACK THROUGH IT, THIS WILL ALSO CAUSE THE NEEDLE TO RESTRAIGHTEN AND BREAK. BD NEEDLE CANNULA ARE ROUTINELY CHECKED FOR REVERSAL TESTING AND BEND STRENGTH TO DETERMINE IF THEY ARE WITHIN THE ESTABLISHED CRITERIA. A POSSIBLE CAUSE ASSOCIATED WITH THIS TYPE OF INCIDENT COULD BE THE ANGLE OF INSERTION. THE FLEXIBILITY OF THE CANNULA IS RELATIVE TO THE GAUGE AND LENGTH. IT IS IMPORTANT DURING INJECTION WITH A NEEDLE CANNULA OF THIS GAUGE, TO MAINTAIN A STRAIGHT AXIAL FORCE TO MINIMIZE DEFLECTION AND SUBSEQUENT BENDING OF THE NEEDLE. IF A NEEDLE BECOMES BENT IT SHOULD BE REPLACED. NO ATTEMPT SHOULD BE MADE TO RE-STRAIGHTEN A BENT NEEDLE SINCE BREAKAGE IS VERY LIKELY TO OCCUR.

    Description of Event or Problem · 1

    ANAESTHESIST, INSERTED A 27G WHITACRE NEEDLE INTO THE BACK OF A MALE PATIENT, NO EXTRA FORCE WAS USED. THERE WAS NO RETURN OF CSF, SO SHE DREW BACK THE NEEDLE AND SHE SAW THAT IT WAS BROKEN. THE PART THAT STAYED BEHIND IN THE PATIENT HAD TO BE REMOVED DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD WHITACRE SPINAL NEEDLE 27G 3 1/2" SPINAL NEEDLE, BULK NON-STERILE BSP BECTON DICKINSON N/A 7080463

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention